MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.019.038S

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/14/2022

Event Type  Injury  

Event Description

Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent surgery to treat humerus.The patient did not underwent unreasonable rehabilitation, but cut-out progressed as the patient progressed to 1 to 2 weeks after the initial surgery.According to surgeon the postoperative reduction was good.A revision surgery is not planned.No further information is available.This report is for one (1) 4.5mm ti multiloc screw length 38mm-sterile.This is report 4 of 7 for complaint (b)(4).

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the provided photo.Visual analysis of the photo revealed was no damage or defects with the tornillo multiloc ø4.5 l38 tan found on the x-ray provided.Not enough evidence to confirmed the complaint.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the tornillo multiloc ø4.5 l38 tan.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H6: a device history record (dhr) review was conducted: part # 04.019.038s, lot # 402p667, manufacturing site: grenchen, release to warehouse date: 29.September.2021, expiry date: 01.September.2031, a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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.

• Brand Name: 4.5MM TI MULTILOC SCREW LENGTH 38MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13765036
• MDR Text Key: 291714470
• Report Number: 8030965-2022-01616
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819430631
• UDI-Public: (01)07611819430631
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.019.038S
• Device Lot Number: 402P667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CASQUILLO-CIERRE MULTILOC P/HN/PHN MULTI; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; LOCKSCR Ø4 L26 F/NAILS TAN DBLUE; PHN MULTILOC Ø9.5 IZQ CAN L160 TAN; TORNILLO MULTILOC Ø4.5 L30 TAN; TORNILLO MULTILOC Ø4.5 L36 TAN
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female