MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	75007307
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr procedure, the plus sl-plus sbg ipa mia offset adapter modular attachment broke outside of the patient.No pieces fell inside of the wound.No injuries, or surgical delays reported.
Additional Manufacturer Narrative
H3, h6: it was reported that during a total hip replacement procedure the plus sl-plus sbg ipa mia offset adapter modular attachment broke outside of the patient.The device, used in treatment, was returned for investigation.Upon visual inspection, the reported failure mode could be confirmed.There was a fracture at the connection between the contact pin and the body of the adapter.A batch record review was performed, but no deviations were found which could relate to the occurred fracture of the device.For the specific batch number no similar complaint can be found.For the specific article number several complaints were recorded reporting a fracture.This instrument is designed to hold and guide the detachable rasps for broaching.It is therefore subjected to repeated impact forces via the modular knock plate or the pneumatic woodpecker.Previous investigations demonstrated, that under specific circumstances, this device may fracture during impaction.An optimized design of the device has been released in order to reduce the occurrence of this issue.S+n will monitor this device for similar issues.The returned device will be discarded.(b)(4).

• Brand Name: PLUS SL MIA DBL OFFSET ADAPT. LT 60/25MM
• 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: 10857539
• Report Number: 9613369-2020-00242
• Device Sequence Number: 2635680
• Product Code: JDI
• UDI-Device Identifier: 07611996074888
• UDI-Public: 07611996074888
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 03/23/2021

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: 75007307
• Device Catalogue Number: 75004612
• Device Lot Number: C63843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 03/19/2021
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/21/2020; 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1