MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RIB HOOK HOLDER; FORCEPS

Catalog Number 03.641.005

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter email address is unavailable.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

(b)(6) reported the following event: it was reported that the rib hook holder would not clasp onto the rib hook.The device malfunction occurred during a planned hardware removal surgery on (b)(6) 2018.The growing rod was removed due to the growth pattern of the patient.The rod was removed whole and intact using a similar back-up instrument.The procedure was successfully completed, with no surgical delay.Patient outcome was reported stable.The device had been in use for 10 years.There was no unusual use of the device.The original implant date was not provided.Concomitant devices reported: veptr implant: rib hook (part: unknown, lot: unknown, quantity: 1).This report is for a rib hook holder.This is report 1 of 1 for (b)(4).

• Brand Name: RIB HOOK HOLDER
• Type of Device: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7546108
• MDR Text Key: 109312091
• Report Number: 2939274-2018-52317
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10705034720135
• UDI-Public: (01)10705034720135
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.641.005
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1