MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCREW SELF-TAPPING 25 MM LENGTH 6.5 MM DIA.; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the sterile package was damaged.No adverse events have been reported as a result of the malfunction.Additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d9, g3, g6, h2, h3, h6, h10.Visual inspection of the returned packaging showed damage to the corner.No punctures or damage through the outer carton were identified.The seal was open upon return.The sterile cavity was removed for inspection and the tyvek seal was found to have been breached with a hole through it.The product was part of a loaner kit and the sterility was breached when opened during a previous procedure.The device history records were reviewed and no discrepancies were identified.The condition of the device when it left zimmer biomet is conforming to specification.The root cause can be attributed to transit damage during redistribution of the product.As the root cause is not a result of a manufacturing or packaging deficiency, zimmer biomet does not consider this event to be reportable.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: BONE SCREW SELF-TAPPING 25 MM LENGTH 6.5 MM DIA.
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• MDR Report Key: 11884881
• Report Number: 0002648920-2021-00122
• Device Sequence Number: 13780490
• Product Code: JDI
• UDI-Device Identifier: 00889024127654
• UDI-Public: (01)00889024127654(17)310728(10)64034114
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K840643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: N/A
• Device Catalogue Number: 00662406525
• Device Lot Number: 64034114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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: N/A
• Patient Sequence Number: 1
• Patient Age: 73 YR