MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG POLARCUP IMPACTOR PART FOR HANDLE; PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED

Model Number 75023344

Device Problems Break (1069); Fracture (1260)

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

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported that during a thr surgery the polarcup reducer part for impactor broke.The procedure was completed, with a non-significant delay, using a s+n back-up device.All pieces recovered from patient's wound.

Manufacturer Narrative

Internal complaint reference: case (b)(4).

Manufacturer Narrative

D4: lot number added.Internal complaint reference: (b)(4).

Manufacturer Narrative

D4: expiration date added.H4: manufacture date added.Internal complaint reference: (b)(4).B5: updated with new part info.D1, d2 updated.D4: catalog number and udi updated.

Event Description

It was reported that during a thr surgery the polarcup impactor part for handle broke.The procedure was completed, with a non-significant delay, using a s+n back-up device.All pieces recovered from patient's wound.

Manufacturer Narrative

H3, h6: it was reported that during a surgery the polarcup impactor part for handle broke.The procedure was completed, using a s+n back-up device.All pieces recovered from patient's wound.The polarcup impactor part for handle (75023346), used in treatment, was received for investigation.The reported failure mode can be confirmed.The device fractured through the notch of the device.The part can be reassembled, therefore, it can be confirmed that all pieces were recovered from the wound.The relationship between the reported event and the device can be confirmed.The production documents could be reviewed.There are no indications that the part failed to match specification at the time of manufacturing.A complaint history review was performed.The complaint is in line with the current risk management of the device.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.Review of past corrective actions was performed.Corrective actions has been previously initiated to reduce the occurrence of this issue.The reported batch was produced before the implementation of the corrective action.No further escalation is required.The received instrument is designed to reposition the polarcup shell.It is therefore subjected to repeated impact forces.Additionally, repeated steam sterilization processes could contribute to an embrittlement.It is however unknown for how many cycles this instrument has been used.A functional test simulating 5 years of use was performed.The observed failure could not be reproduced.Based on the conducted investigations the root cause of the fracture could therefore not be determined conclusively, however might be attributed to a design issue.Nonetheless, in combination with our continuous effort to improve our products, design changes have been implemented as mentioned above.No further actions are deemed necessary at the time.Smith+nephew will continue to monitor for similar issues.The device will be discarded.

• Brand Name: POLARCUP IMPACTOR PART FOR HANDLE
• Type of Device: PROSTHESIS, HIP, HEMI-, FEMORAL, METAL/POLYMER, CEMENTED OR UNCEMENTED
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS AG; schachenallee 29; aarau CH-50 00; SZ CH-5000
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13777698
• MDR Text Key: 287254874
• Report Number: 9613369-2022-00051
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 07611996112351
• UDI-Public: 07611996112351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 75023344
• Device Catalogue Number: 75023346
• Device Lot Number: A56335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/16/2022
• Supplement Dates Manufacturer Received: 02/24/2022; 02/24/2022; 05/02/2022
• Supplement Dates FDA Received: 03/30/2022; 04/21/2022; 05/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention