MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN STRAIGHT CUP IMPACTOR; HIP INSTRUMENTS : IMPACTORS

Catalog Number 221750041

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the back of black cup impactor broke off.Threads on white handle cup impactor were smashed.No surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : examination of the returned instrument confirmed the complaint.The root cause is attributed to use error through off axis impact.Complaints will be monitored under sep 419 post market surveillance.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Territory 238 reports that the back of black cup impactor broke off.No surgical delay.Examination of the returned instrument confirmed the complaint; the metal end of the handle broke off.The complaint sample consisted of (1) 221750041 pinnacle straight cup impactor.A search of the complaint database by product code identified a trend of handle breakages.A previous investigation (sem investigation) was conducted by a depuy material scientist in 2014 for handle fractures.Three submitted impactors were evaluated and found the instruments fractured through the pinnacle impactor end cap.The evaluation found the impactors were repeatedly loaded in rotating bending fatigue beyond the material limit resulting in fatigue crack initiation and propagation with mixed-mode overload final fracture of the material.The fracture features were consistent with the rotating bending fatigue from striking the end cap off-axis from a perfect end strike, possibly in multiple various directions.The hardness testing confirmed the material met the engineering drawing specification.The previous sem evaluation is in the attachment section.Commercialized product development has been made aware of this failure through weekly department complaint handling unit/commercialized product development meetings and is currently reviewing the design.Visual analysis also observed a portion of the top thread broke off.A functional check with a mating cup found the threaded tip would not assemble into the cup as intended.A search of the complaint database found the lead thread of the impactor most likely cross threaded into the cup.This type of damage is typically caused when the item is impacted when not fully threaded into the mating item.The load of the impact is transferred to the threads rather than the shaft.Complaints will be monitored under post market surveillance sep 419.Device history lot : null.Device history batch : null.Device history review : null.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.The root cause is attributed to use error through off axis impact.Complaints will be monitored under sep 419 post market surveillance.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PINN STRAIGHT CUP IMPACTOR
• Type of Device: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9274449
• MDR Text Key: 184848108
• Report Number: 1818910-2019-113952
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295098980
• UDI-Public: 10603295098980
• Combination Product (y/n): N
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 221750041
• Device Lot Number: SO2037887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 11/20/2019; 11/20/2019
• Supplement Dates FDA Received: 11/22/2019; 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1