MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SUTURE CROCHET HOOK; INSTRUMENT, SPORTS MED

Catalog Number	903610
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device product code: (b)(4).Report source: (b)(6).Visual examination of the returned product determined that the tip of crochet hook is actually fractured and tip was not returned.The device is almost 4 years old and shows signs of use.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported during the inspection of the kit the tip of the product was discovered as fractured.It is unknown when the break occurred.Attempts have been made and no further information has been provided.

• Brand Name: SUTURE CROCHET HOOK
• Common Device Name: INSTRUMENT, SPORTS MED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10560923
• Report Number: 0001825034-2020-03543
• Device Sequence Number: 19573841
• Product Code: GDG
• UDI-Device Identifier: 00880304404939
• UDI-Public: (01)00880304404939
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 903610
• Device Lot Number: 785350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1