MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 19MM WIDE

Model Number	399.122
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 on an unknown date, a bone holding forceps was being washed at the sterile processing department, got caught at one side of the cases, and as they tried to remove by putting a lot of force on it, the tip of the bone holding forceps broke off.There was no patient involvement.This report is for a bone holding forceps.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.A review of the device history record device history lot.Part: 399.122, lot: n2002, manufacturing site: bettlach, release to warehouse date: 06.Mar.2001.Dhr not available as device is older than 18 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se_075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.Investigation summary background: it was reported that on an unknown date, a bone holding forceps was being washed at the sterile processing department, got caught at one side of the cases and as they tried to remove by putting a lot of force on it, the tip of the bone holding forceps broke off.There was no patient involvement.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the bone holding forceps-soft ratchet f/plates to 19mm wide (p/n 399.122 lot 4292469) was received showing one of the forceps tips broken off.The broken off tip was returned.No other issues were identified with the returned components of the device.The device failure/defect of broken tip was identified during the investigation and is related to the reported complaint condition.Dimensional inspection: dimensional inspection of the forceps tip was not conducted due to post manufacturing damage and broken off tip.There is no indication that a manufacturing or design issue caused this complaint condition due to the provided information.The condition of the returned device shows that it has been heavily used/reprocessed in the field over its lifetime (18+ years).Document/specification review: the manufactured revision was unable to be accessed/reviewed as the device was manufactured by mathys prior to the oldest available drawing available in synthes systems.Because the device was made in 2001 (18+ years old) , there is no indication that a design or manufacturing issue contributed to the complaint condition.Conclusion: the complaint condition is confirmed for the bone holding forceps-soft ratchet f/plates to 19mm wide (p/n 399.122 lot 4292469) as one of the forceps tips was broken off.The broken off tip was returned.While no definitive root cause could be determined, based on the information available, it is likely that the tip broke off due to excessive force by the user trying to remove the device from the case.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Lot updated for reporting.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.

• Brand Name: BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 19MM WIDE
• Common Device Name: FORCEPS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8842954
• Report Number: 2939274-2019-59450
• Device Sequence Number: 13857509
• Product Code: HTD
• UDI-Device Identifier: 10886982202376
• UDI-Public: (01)10886982202376
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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: 399.122
• Device Catalogue Number: 399.122
• Device Lot Number: 4292469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1