MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HASTINGS CORK SCREW/HEAD EXT.; HIP INSTRUMENTS : SCREWDRIVERS

Catalog Number 963253000

Device Problems Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(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

Hospital called to report that surgeons using the single piece cork screw t-handle (femoral head extraction tool) during hemi-arthroplasty and thr cases are not happy with the way the instrument is performing, nurse reported that surgeons complain the design is not suitable causing the cork screw to pull out of the bone too easily (i.E.Will not get good enough purchase).They are using a hospital owned t handled corckscrew with a thicker shaft and end as a back up / replacement for surgeons that do not wish to use the one in the depuy kits.The hospital would like to look into depuy alternatives and replace out.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 : no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.A review of complaint databases did not identify any anomalies.It should be noted that no device was returned.- without the physical complaint sample(s) associated with this report, it was not possible to determine if the device(s) failed to meet specification(s) at the time it was released for distribution.- the device(s) associated with this event were used in the treatment of the patient as prescribed by the presiding surgeon.- from the event information received, it was not possible to determine the relationship of the device to the reported event.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The complaint shall be closed with an undetermined conclusion; entered into the complaints database and monitored through trend analysis.Post market surveillance is per sep 419.Device history lot: null.Device history batch: null.Device history review: null all medical device reports associated with the same/similar device(s) and upon receipt: dimensional were reviewed.It was determined upon receipt: dimensional has not caused or contributed to any deaths or serious injuries within the time period of jan 1, 2020 ¿ may 17, 2023.In total, there have been zero serious injuries and zero deaths reports related to upon receipt: dimensional in the last 3.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, upon receipt: dimensional associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.

• Brand Name: HASTINGS CORK SCREW/HEAD EXT.
• Type of Device: HIP INSTRUMENTS : SCREWDRIVERS
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9995383
• MDR Text Key: 191146873
• Report Number: 1818910-2020-11252
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2020

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: 963253000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 05/20/2020; 05/18/2023
• Supplement Dates FDA Received: 05/21/2020; 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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