MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X20 SELF-TAP; PROSTHESIS, HIP

Catalog Number 00625006520

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).G2: china.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 Description

It was reported that during the initial procedure, the screw was found to be bend and could not be implanted with the instrument.Attempts have been made and no further information is available.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: b4; b5; d9; g3; h2; h3; h4; h6.Visual examination of the returned product identified it is difficult to determine if the screw is bent visually.The head though is deformed.See photos marked warped head.The threads are not damaged.The anodize coating is not scrapped off.The major diameter of the threads is in spec.The head of the screw is non-conforming to the print.During the examination of the screw head, it was discovered that there is a crack in the head of the screw that travels down part of the broach of the hex feature and across part of the face of the head.The hex feature does not have any deformed edges that is typical of a device that has been used with a driver bit.The anodize coating is consistent and not scratched off in the broached area.Spec for the head diameter is.303 +0 -.006; measurement is out of spec measuring.31985 &.26445.Spec for the overall length is.787 +\-.010; measurement is non-conforming at.8111 because the material is folded up.The complaint is confirmed based on the returned device.Dhr was reviewed and no discrepancies related 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.

• Brand Name: BONE SCR 6.5X20 SELF-TAP
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18100580
• MDR Text Key: 327718636
• Report Number: 0002648920-2023-00267
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 00889024119802
• UDI-Public: (01)00889024119802(17)320905(10)65577233
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00625006520
• Device Lot Number: 65577233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female