MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75007309
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when attaching the first broach to the broach handle, the broach fell off the of the handle.Then, it was noticed that the locking mechanism was broken.The offset broach handle was used instead with no adverse consequences.This was noticed during set up/inspection.
Additional Manufacturer Narrative
It was reported that when attaching the first broach to the broach handle, the broach fell off the of the handle.Then, it was noticed that the locking mechanism of the sl-plus/sbg/ipa mia offset adapter 10mm [article no.: 75007309, lot: e59830] was broken.The offset broach handle was used instead with no adverse consequences.This was noticed during set up/inspection.The claimed article, which intent use is in treatment, was returned for investigation.The reported failure can be confirmed.The device is fractured at the locking mechanism.The hook was broken off.The review of the order documentation did not reveal any deviation which could relate to the reported failure.A complaint history review was performed: for the batch in scope no other complaint was recorded.For the specific article number overall 8 complaints are recorded which state a fracture of the device.Due to the performed complaint review it will not assumed that a manufacturing error happened.The ifu (lit.No.12.23 ed 05/16) requires "before use, the functionality of surgical instruments should be checked." all reusable instruments shall therefore be routinely inspected for functionality, wear and damage and replaced as necessary.To date, no further actions will be taken.The root cause will be state to "cause traced to component failure".The device will be discarded.Smith & nephew will monitor this device for similar issues.

• Brand Name: SL-PLUS/SBG/IPA MIA OFFSET ADAPTER 10MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• MDR Report Key: 11654378
• Report Number: 9613369-2021-00155
• Device Sequence Number: 17017916
• Product Code: JDI
• UDI-Device Identifier: 07611996076394
• UDI-Public: 07611996076394
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2021

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 Expiration Date: 04/02/2015
• Device Model Number: 75007309
• Device Catalogue Number: 75007309
• Device Lot Number: E59830
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1