MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DHS®/DCS® IMPACTOR

Catalog Number	338.28
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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
It was reported during an unknown procedure on (b)(6) 2018, while using the mallet and impactor to push the dhs plate to the bone, a piece of the gray plastic impactor broke off.The piece was retrieved easily without additional intervention, and the impactor was still usable enough to finish the case.There was no patient impact.The surgery was completed successfully with no delay.Concomitant device(s) reported: impaction inst: hammer/mallet: tr (part #: unknown, lot #: unknown, qty: 1) dhs/dcs plate (part #: unknown, lot #: unknown, qty: 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Corrected data: weight unit is unknown as weight is unknown.Event date was corrected to: (b)(6) 2018.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: DHS®/DCS® IMPACTOR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7597354
• Report Number: 2939274-2018-52494
• Device Sequence Number: 16175639
• Product Code: HWA
• UDI-Device Identifier: 10886982193308
• UDI-Public: (01)10886982193308
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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 Catalogue Number: 338.28
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1