MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4/2.7MM VA-LCP BENDING PLIER; PLIERS, SURGICAL

Model Number	03.211.005
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Reporter is a synthes employee.Part: 03.211.005, lot: t948737, manufacturing site: (b)(4), release to warehouse date: september 27, 2010.A review of the device history records was performed for the finished device lot number, and no non-conformance's were identified.Visual inspection: the 2.4/2.7mm va-lcp bending plier was received at us customer quality (cq).Visual inspection of the complaint device showed the compression springs part 329_146_9 and 329_146_8 were deformed.Functional test: during the functional assessment, compression was applied to both handles by squeezing them but not locking them.After release of the grip to unload the compression, the handles did not retract back to their resting position.The functional test failed.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Also, measurement of relevant parts of the device would require the device to be disassembled.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the springs of the device were found deformed.No root cause could definitively be determined for the reported complaint condition.No new, unique, or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during inspection of back up items on unknown date, some were set aside for expired exchange.One (1) bending pliers have no tension.Two (2) topcoat from the depth gauges are peeling.One (1) handle with quick coupling gets stuck.One (1) universal drill guide has pitting on the handle.One (1) stardrive screwdriver is losing its shape.And two (2) socket wrenches have pitting on the swivel.There was no patient involvement.This report is for a 2.4/2.7mm va-lcp bending plier.This is report 1 of 3 for (b)(4).

• Brand Name: 2.4/2.7MM VA-LCP BENDING PLIER
• Common Device Name: PLIERS, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11791784
• Report Number: 2939274-2021-02261
• Device Sequence Number: 1020521
• Product Code: HTC
• UDI-Device Identifier: 10886982076038
• UDI-Public: (01)10886982076038
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.211.005
• Device Catalogue Number: 03.211.005
• Device Lot Number: T948737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1