MAUDE Adverse Event Report: RICHARD WOLF GMBH PUNCH 2.6MM WL 290MM; PUNCH Ø 2.6MM WL 290MM

Model Number 89240.2225

Device Problem Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation of the device is in progress.The device has been returned to richard wolf (b)(4) by the user and a follow-up report will be issued as soon as the investigation is completed.

Event Description

During endoscopic spine surgery at l5-s1 (interlaminar approach) distal part of instrument has feil out to spinal canal conversion surgery to mini open was necessary.Surgery was performed by certified spine surgeon by (b)(6).Probably distal part of instrument has feil out when surgeon was cutting anulus.Client use mentioned instrument only for approx.3 surgeries before incident.(b)(6) has checked all procedures which are applied in hospital (reprocessing, cleaning etc.) and all rw user manuals guidelines are properly apply by client.Client demand replacement for new instrument under warranty.Patient is under constant control at outpatient clinic.Surgery conversion to mini open in conjunction with trying to find foreign body of richard wolf instrument and end of surgery.Time of delay surgery was approx.3 hours.Foreign part of rw instrument left inside patient body.

Manufacturer Narrative

Richard wolf mic is submitting this report on behalf of richard wolf gmbh.During use, the distal hinge pin failed and remained intracorporal.The cause of this fracture or loss of parts could not be determined, as the pin was not available for examination.In principle, the built-in tension joint (overload protection) protects these forceps from overload by design: the force in the tie rod required to shear the pin when installed is 477.4n +/-8.3n.Theoretically, when the jaw is fully open and blocked, and the handle stop is reached, only a maximum pulling force of 370n can be achieved.This value represents the theoretical maximum when used for other purposes (manipulation of metal implants or similar) and does not take into account all the inherent elasticities of the complete forceps.On a punch from a current batch, the force required to shear the pin in the installed state was determined to be 559n in the pull rod.The overall characteristic curve of the punch from the current batch (i.E.Stress-restrained plus other elasticities such as the shaft tube and tie rod) resulted in a maximum tensile force in the tie rod of approx.225n in the fully locked state.This means that in the practical case, the safety against pin overload is again significantly higher.It was not possible to determine the cause of this breakage or loss of parts, as the pin was not available for examination.The 892402225 pen ø 2.6mm nl 290mm from during use, the distal hinge pin failed and remained intracorporal.The cause of this fracture or loss of parts could not be determined, as the pin was not available for examination.In principle, the built-in tension joint (overload protection) protects these forceps from overload by design: the force in the tie rod required to shear the pin when installed is 477.4n +/-8.3n.Theoretically, when the jaw is fully open and blocked, and the handle stop is reached, only a maximum pulling force of 370n can be achieved.This value represents the theoretical maximum when used for other purposes (manipulation of metal implants or similar) and does not take into account all the inherent elasticities of the complete forceps.On a punch from a current batch, the force required to shear the pin in the installed state was determined to be 559n in the pull rod.The overall characteristic curve of the punch from the current batch (i.E.Stress-restrained plus other elasticities such as the shaft tube and tie rod) resulted in a maximum tensile force in the tie rod of approx.225n in the fully locked state.This means that in the practical case, the safety against pin overload is again significantly higher.It was not possible to determine the cause of this breakage or loss of parts, as the pin was not available for examination.The 892402225 pen ø 2.6mm nl 290mm from batch 1428840 was posted to stock on 11/19/2020.With the corresponding production order 1428840, a total of 10 pieces of the 892402225 stanze ø 2,6mm nl 290mm were produced.To the customer 1 piece of the 892402225 stanze ø 2,6mm nl 290mm from the batch 1428840 was delivered on 11/21/2019.In general, the user is advised in the associated instructions for use ga-s003 under chapter 9 that a visual and functional check must be carried out before and after each use.Possible possible damage or functional impairment can be easily detected by hospital personnel if these instructions are followed.Chapter 8 draws the user's attention to the limited stability of the products! excessive application of force leads to damage, impairs the function and thus endangers the patient.Check products immediately before and after use for damage, loose parts and completeness.No missing parts may remain in the patient.Do not use products which are damaged, incomplete or have loose parts.Possible hazards have been considered in the b1-2 r05 risk assessment with the corresponding extent of damage and probability of occurrence and have been assessed as an acceptable risk.This assessment is still valid even considering the current case.In our b1-2 r05 risk analysis, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks from an unusable product were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed with an acceptable risk.A detailed risk analysis was carried out during the development of the product.The user error described was identified and evaluated as a possible error.In the b1-2 r05 risk assessment, the extent of damage and with the assumed probability of occurrence was considered and assessed with an acceptable risk.According to risk assessment b1-2 r05.Hazard (2): 5.7 hazard due to product combinations.Functions/components (3): 3product complete.Causes (3): 5.4 handling-related -> 5.4.8 wear-increasing application.Damage (2): irreversible damage.Richard wolf gmbh(rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation(rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.Batch 1428840 was posted to stock on 11/19/2020.With the corresponding production order 1428840, a total of 10 pieces of the 892402225 stanze ø 2,6mm nl 290mm were produced.To the customer 1 piece of the 892402225 stanze ø 2,6mm nl 290mm from the batch 1428840 was delivered on 11/21/2019.In general, the user is advised in the associated instructions for use ga-s003 under chapter 9 that a visual and functional check must be carried out before and after each use.Possible possible damage or functional impairment can be easily detected by hospital personnel if these instructions are followed.Chapter 8 draws the user's attention to the limited stability of the products! excessive application of force leads to damage, impairs the function and thus endangers the patient.Check products immediately before and after use for damage, loose parts and completeness.No missing parts may remain in the patient.Do not use products which are damaged, incomplete or have loose parts.Possible hazards have been considered in the b1-2 r05 risk assessment with the corresponding extent of damage and probability of occurrence and have been assessed as an acceptable risk.This assessment is still valid even considering the current case.In our b1-2 r05 risk analysis, manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks from an unusable product were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed with an acceptable risk.A detailed risk analysis was carried out during the development of the product.The user error described was identified and evaluated as a possible error.In the b1-2 r05 risk assessment, the extent of damage and with the assumed probability of occurrence was considered and assessed with an acceptable risk.According to risk assessment b1-2 r05.Hazard (2): 5.7 hazard due to product combinations.Functions/components (3): 3product complete.Causes (3): 5.4 handling-related -> 5.4.8 wear-increasing application.Damage (2): irreversible damage.Richard wolf gmbh(rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation(rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.

• Brand Name: PUNCH 2.6MM WL 290MM
• Type of Device: PUNCH Ø 2.6MM WL 290MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11382160
• MDR Text Key: 259314494
• Report Number: 9611102-2021-00010
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04055207035559
• UDI-Public: 04055207035559
• Combination Product (y/n): N
• PMA/PMN Number: 888.4540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 89240.2225
• Device Lot Number: 1428840
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other