MAUDE Adverse Event Report: SYNTHES GMBH PROTECT SLEEVE 12/8 L188; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 03.010.063

Device Problems Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j sales representative.Mfr site: postal code (b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in portugal as follows: it was reported on an unknown date that - 03.010.041 b 14.0/3.2 mm punzón, damaged canulated.Replace.03.010.063 hystic protection plane 12.0/8.0, longitud 188 mm, and a 03.010.065 bit guide 8.0/4.2, for part no.03.010.063, very difficult to remove from each other, check there was no surgical delay.There was alteration of the technique by another surgical option existing in the surgical instrument, with no impact on the surgery.There was no patient consequences.This report is for one (1)protect sleeve 12/8 l188.This is report 3 of 3 for complaint (b)(4).

Event Description

Device report from synthes reports an event in portugal as follows: it was reported on an unknown date that - 03.010.041 b 14.0/3.2 mm punzón, damaged canulated.Replace.03.010.063 hystic protection plane 12.0/8.0, longitud 188 mm, and a - 03.010.065 bit guide 8.0/4.2, for part no.03.010.063, very difficult to remove from each other, check there was no surgical delay.There was alteration of the technique by another surgical option existing in the surgical instrument, with no impact on the surgery.There was no patient consequences.The procedure was completed successfully.This report is for one (1) protect sleeve 12/8 l188 this is report 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Depuy synthese 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the event description has been updated accordingly.

Event Description

The initial complaint was reviewed and found not reportable.The event was inaccurately reported as an incident.There is no allegation against this device.The accurate determination for the reported device is not reportable.

• Brand Name: PROTECT SLEEVE 12/8 L188
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15190830
• MDR Text Key: 304984394
• Report Number: 8030965-2022-05651
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819760905
• UDI-Public: (01)07611819760905
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: EXEMPT
• 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

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: 03.010.063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 08/11/2022; 10/11/2022
• Supplement Dates FDA Received: 08/31/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1