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	75004612
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that an attachment of the plus sl-plus mia dbl offset adapt.Has broken off in the strike plate.Device broke during use, while inside the patient.Procedure was completed using a s+n backup device.No surgical delay or injury to the patient was reported.
Additional Manufacturer Narrative
Investigation results: it was reported that the attachment of the plus sl-plus mia double offset adapter has broken off in the strike plate.No surgical delay or injury to the patient was reported.The device, used in treatment, was returned for investigation.Upon visual inspection, the fracture at the connection between the contact pin and the body of the adapter could be confirmed.Apart from that, the device shows normal signs of usage such as small dents and scratches.According to document "processing (cleaning, disinfection and sterilization) of instruments from smith & nephew orthopaedics ag" (lit.N°03389-en 1363 v3 11/19), all instruments must be inspected and controlled for proper functioning after cleaning/disinfection.Instruments should only be used in their original condition (lit.No.12.23 ed.05/16).Furthermore, the failure mode and the severity are covered through our risk management.A review of the production documentation did not detect any deviation that could have contributed to the reported failure mode.Furthermore, possible raw material certificates of the batch in question were additionally reviewed, but no deviation was detected as well.No additional complaint was detected for the batch in question (c61623).A medical investigation could not be performed as relevant clinical information has not been provided.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.This version of the device will be monitored for similar issues.The returned device will be discarded.

• 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: 11194293
• Report Number: 9613369-2021-00037
• Device Sequence Number: 703571
• Product Code: JDI
• UDI-Device Identifier: 07611996085464
• UDI-Public: 07611996085464
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 75004612
• Device Catalogue Number: 75004612
• Device Lot Number: C61623
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention