MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.; INSTRUMENT, EXTREMITIES

Catalog Number	00249003244
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 that approximately two (2) weeks ago, the tip of the impactor broke during surgery.Surgeon removed the broken piece from the patient, so no pieces were retained.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g4; g7; h1; h2; h3; h6.Visual examination of the provided pictures identified the reamer broke at the distal end.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.A possible contributing factor was noted to be lag screw pin was not central in lag screw hole in cm nail, however, as the reamer was not returned for evaluation, this could not be confirmed.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
No further event information available at the time of this report.

• Brand Name: CEPHALOMEDULLARY LAG SCREW REAMER LONG 3.2 MM I.D.
• Common Device Name: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10757505
• Report Number: 0001822565-2020-03671
• Device Sequence Number: 19097983
• Product Code: HSB
• UDI-Device Identifier: 00889024063532
• UDI-Public: (01)00889024063532
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: 00249003244
• Device Lot Number: 64035394
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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