MAUDE Adverse Event Report: SYNTHES TUTTLINGEN PERIARTICULAR REDUCTION FORCEPS-LARGE

Model Number	398.228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.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 phone number: (b)(6).A device history record (dhr) review was performed for part # 398.228 / lot # a7ma43 / 4675650: manufacturing date: week 43 in 2003.The dhr is no longer available in (b)(4) due to the age of the instrument (over 14 years old).The exact date of manufacture is unknown.Service and repair serive history review performed on part # 398.228 / a7ma43 / 4675650: no service history review can be performed as part number 398.228 with lot number(s) a7ma43 / 4675650 is a lot/batch controlled item.The service history review is unconfirmed.Please launch a device history record (dhr) review.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that two (2) cannulated screwdrivers and a periarticular reduction clamp were reported broken by the operating room.This report is for one (1) periarticular reduction forceps-large this is report 3 of 3 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: device is not expected to be returned for manufacturer review/investigation.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.Device 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
Update - received info/email from sales consultant, that clamp will not be returned.

• Brand Name: PERIARTICULAR REDUCTION FORCEPS-LARGE
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 7035014
• Report Number: 9680938-2017-10144
• Device Sequence Number: 2036644
• Product Code: HTD
• UDI-Device Identifier: 10886982201324
• UDI-Public: (01)10886982201324(10)A7MA43
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2017

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: 398.228
• Device Catalogue Number: 398.228
• Device Lot Number: A7MA43
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1